Diving into DQSA: Getting in Deep – RX Repackaging

One major change to §503A was the removal of the word “repackaging” from the definition of compounding! That enabled the FDA to align this very traditional role for compounders with their control over federally registered repackagers and relabelers. Do you know whether what you’re doing is repackaging? Compliant with federal and state law? Whether you need an additional permit or registration? Get the answers!

This lesson is a knowledge-based CE activity and is targeted to pharmacists and technicians.

ACPE logo The American College of Apothecaries (ACA) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACA has accredited this program for 1.0 contact hours (0.1 CEUs) of continuing education credit for pharmacists and technicians. 0201-9999-15-066-L04-P; 0201-9999-15-066-L04-T.

If you are interested in earning credit for this program, please note that you will be asked to enter your NABP e-Profile ID during the credit selection step of the registration process. If you have not yet registered your NABP e-Profile ID, please visit www.nabp.net.

CE credit and certificates of attendance will be provided only to those individuals who registered and logged into the webinar online. If you want CE credit and your certificate of attendance, you must have purchased the program and logged into the web portion under that registration so that we can verify attendance.

At the conclusion of this program, the pharmacist and technician attendee will be able to:

List the six types of lists specified in 503A and 503B of DQSA
Explain why repackaging of manufactured products is not covered under sections 503A and 503B of DQSA
Contrast the labeling requirements and record keeping requirements for repackaged products by 503A compounders and 503B outsourcing facilities
Describe the record keeping requirements under federal oversight for repackaged sterile and non-sterile products
Identify three resources for remaining up to date on changes to repackaged requirements.

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